Phase 2
N=229
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Vulvovaginal Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT01144286 ↗Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Dose-response of Clinical and Mycological (Global) Therapeutic Response — 31.7; 48.7; 47.6; 53.8 percentage of patients cured — p=0.0630
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- arasertaconazole nitrate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferrer Internacional S.A.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-response of Clinical and Mycological (Global) Therapeutic Response |
31.7; 48.7; 47.6; 53.8 | 0.0630 |
| SECONDARY Dose-response of Clinical and Mycological (Global)Therapeutic Response |
15.6; 34.2; 46.3; 61.0 | — |
Summary
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
Eligibility Criteria
Inclusion Criteria
- Women aged between 18 to 65 years of age who have signed the informed consent.
- Not pregnant, not nursing.
- No indication of other vulvovaginitis or genital infections
- Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
- Negative wet mount results for T. vaginalis and clue cells.
- Exclusion Criteria:
- Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
- Hypersensitivity to imidazole products administered topically.
- Any other medical condition which in the opinion of the investigator could interfere with study conduct.
Data sourced from ClinicalTrials.gov (NCT01144286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.